Overview

This project involved the provision of strategic advice and technical services for the recommendation and selection of::

• Aseptic bottle dispensing equipment for the manufacture of a large volume veterinary injectable product.
• Labelling and cartoning equipment used in the manufacture of a large volume veterinary injectable product.
• Syringe de-nesting, inspection, plunger rod insertion, labelling and accumulation equipment for the packaging of veterinary injectable product.
• Aseptic vial dispensing equipment for the manufacture of a small volume veterinary injectable product.
• Inspection, labelling and cartoning equipment for the packaging of small volume veterinary injectable product.

Our Role

Business Biotics Group scope included:

• The preparation of User Requirement Specifications for the equipment
• Project management of the tender phase involving:
• Co-ordination of tender responses and technical communication with suppliers
• Completion of supplier comparative analysis studies
• The submission of an Equipment Selection Report
• Completion of the Design Qualification
• Completion of the Factory and Site Acceptance Testing
• Completion of the Installation Qualification

Overview

QIMR require GMP licensure for the aseptic manufacture of Phase I/II clinical trial product. The existing facility, plant and equipment required an upgrade to accommodate vigorous aseptic processing regulations. The situation was challenging and required expertise and experience as the facility was multifunctional and contained a number of different operational scenarios, including PC2 containment, fermentation suites, laboratories and cleanrooms. The strategic objective of QIMR was to achieve licensure in the most cost efficient manner possible.

Our Role

Our role was to conduct an initial audit of the existing facility and recommend a number of key strategies including:

• Re-draft and update the QIMR Facility Site Master File.
• Update the QIMR Quality Manual.
• The selection of small scale aseptic dispensing equipment.
• The selection of a GMP pilot scale autoclave.
• The selection of a pilot scale depyrogenation oven.
• Design of a pilot scale Grade A laminar flow dispensing cabinet.
• The selection of a range of suitable vials stoppers and caps.
• Design a revised facility air pressure differential regime including negative pressure PC2 containment, clean fermentation areas, aseptic processing areas and laboratories.
• Specify a URS for a new Highly Purified Water System.

Outcomes

Our results were commensurate with QIMR’s requirement to contain costs and provide viable solutions to achieve the strategic goal of GMP compliance for the aseptic manufacture of Phase I/II clinical trial product. Business Biotics Group provided the expertise and assisted QIMR to set the order of priorities.
We have completed our scope of work. The dispensing system has been installed, modifications to the HVAC systems are proceeding and the remaining equipment is in the process of being ordered.
QIMR is now poised to achieve licensure for the aseptic manufacture of Phase I/II clinical trial product.

Please contact Business Biotics Group if a QIMR reference is required.

Overview

General Dynamics Information Technology is a United States top-tier IT integrator that provides information technology, systems engineering and professional services to customers in the defence, intelligence, and homeland security, federal, civil and commercial sectors.

Business Biotics Group was contracted by General Dynamics Information Technology who acted as the contract agents for The United States Army Medical Research and Materials Command, Fort Detrick Maryland.

Outcomes

The scope of works activities were accomplished on time and on budget. General Dynamics Information Technology delivered the final report package to United States Army Medical Research and Materials Command, in October 2006.
Business Biotics Group used a number of critical analysis techniques to formulate the final recommendations for the United States Army Medical Research and Materials Command. The first of these techniques was the completion of a Net Present Value Analysis which compared the potential return on investment utilizing a matrix of different active ingredients and manufacturing technology scenarios. The second was a market analysis which predicts the market potential of the product. Information was gathered from leading US trauma surgeons that culminated in the identification of critical civilian trauma uses and potential market sizes.
A Technology Roadmap was developed that crystallized a viable commercial strategy that will enable the United States Army Medical Research and Materials Command to progress the hemostatic dressing towards commercial registration.

Due to confidentiality agreements and IP restrictions, it is not possible to detail the information contained in the final submission report. However, the success of this Project can be measured by the fact that the United States Army Medical Research and Materials Command is continuing discussions with General Dynamics Information Technology to progress towards the commercial manufacture of the hemostatic dressing for battlefield use.